| Device |
weights, eyelid, external |
| Regulation Description |
Eyelid weight. |
| Definition |
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure) |
| Physical State |
An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. |
| Technical Method |
It uses gravity/weight of the metal to assist in closure of the eyelid. |
| Target Area |
Eyelid |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | MML |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
886.5700
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
